BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 10586561 · Received September 25, 2020

    Report

    Report Number
    2243072-2020-01501
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 7, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JPH
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 2020-09-07 H.6. INVESTIGATION SUMMARY BD RECEIVED THE FAULTY INSTRUMENT FROM THE CUSTOMER FOR INVESTIGATION. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE SPROCKET THAT DRIVES THE TUBE HOLDER WAS FOUND TO BE LOOSE. THE SPROCKET WAS RE-SEATED AND THE INSTRUMENT WAS CONFIRMED TO MEET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD SEDI-40 HAD HARDWARE / SOFTWARE MALFUNCTION FOR ESR INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MIXER DOES NOT WORK ( IT IS "ON" IN A SETUP)¿

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD SEDI-40 HAD HARDWARE / SOFTWARE MALFUNCTION FOR ESR INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MIXER DOES NOT WORK ( IT IS "ON" IN A SETUP).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055240 BD SEDI-40 ESR INSTRUMENT JPH BECTON DICKINSON 15-42008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other